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Publication numberUS20100256595 A1
Publication typeApplication
Application numberUS 12/417,789
Publication dateOct 7, 2010
Filing dateApr 3, 2009
Priority dateApr 3, 2009
Also published asCN102438672A, CN102438672B, EP2413989A1, EP2413989B1, US8313954, US8992862, US20130068676, WO2010115190A1
Publication number12417789, 417789, US 2010/0256595 A1, US 2010/256595 A1, US 20100256595 A1, US 20100256595A1, US 2010256595 A1, US 2010256595A1, US-A1-20100256595, US-A1-2010256595, US2010/0256595A1, US2010/256595A1, US20100256595 A1, US20100256595A1, US2010256595 A1, US2010256595A1
InventorsMichael D. Leach, Jason Chavarria
Original AssigneeBiomet Biologics, Llc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
All-In-One Means Of Separating Blood Components
US 20100256595 A1
Abstract
A separation device including a first buoy, a second buoy, a first valve, and a second valve. The first buoy is mounted to a buoy guide post and slidably mounted within a separation chamber. The second buoy is slidably mounted to the guide post and movable between a first position and a second position. The second buoy closes the first valve and opens the second valve when in the first position. The second buoy opens the first valve and closes the second valve when in the second position. The second buoy has a density such that after spinning the device for a suitable period of time a first component of the composition is isolated between the first buoy and the second buoy and a second component of the composition is isolated between the second buoy and the end of the separation chamber that is opposite to a port.
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Claims(33)
1. A device having a separation chamber for separating components of a composition according to density comprising:
a port that provides fluid communication between an interior and an exterior of said separation chamber;
a buoy guide post;
a first buoy fixedly mounted to said buoy guide post and slidably mounted within said separation chamber;
a second buoy slidably mounted to said buoy guide post and movable between a first position and a second position along said buoy guide post;
a passage defined in said buoy guide post that is in fluid communication with said port;
a first valve in said buoy guide post in fluid communication with said passage and an area of said separation chamber between said first buoy and said second buoy;
a second valve in said buoy guide post in fluid communication with said passage and an area of said separation chamber between said second buoy and an end of said separation chamber that is opposite to said port;
wherein said second buoy closes said first valve and opens said second valve when in said first position; and
wherein said second buoy opens said first valve and closes said second valve when in said second position; and
wherein said second buoy has a density such that after spinning said device for a suitable period of time a first component of said composition is isolated between said first buoy and said second buoy and a second component of said composition is isolated between said second buoy and said end of said separation chamber that is opposite to said port.
2. The device of claim 1, wherein said port provides a passageway to said separation chamber for inserting the composition into said separation chamber and for withdrawing the separated components from said separation chamber.
3. The device of claim 1, further comprising a plunger that is slidably movable within said separation chamber, said plunger includes a plunger base that is removably attached to a plunger handle.
4. The device of claim 3, further comprising a plunger stop that restricts movement of said plunger.
5. The device of claim 1, wherein said first buoy has a density of between about 1.070 g/ml and about 1.095 g/ml.
6. The device of claim 1, wherein said first buoy has a greater density than said second buoy.
7. The device of claim 1, wherein said second buoy has a density of between about 0.93 g/ml and about 0.955 g/ml.
8. The device of claim 1, wherein said first buoy has a top surface that faces said second buoy, said top surface is concave; and
wherein said first buoy has a bottom surface that is opposite to said top surface, said bottom surface is convex.
9. The device of claim 1, wherein said device includes a syringe.
10. The device of claim 9, wherein said syringe is connected to said port with an extension nozzle.
11. The device of claim 9, wherein said syringe is connected directly to said port.
12. The device of claim 1, wherein said composition includes one of the following: whole blood, blood plasma, mononuclear cells, bone marrow aspirate, spinal fluid, and fat.
13. The device of claim 1, wherein said first and said second buoys are of a density that permits isolation of the following: platelet rich plasma between said first buoy and said second buoy; red blood cells on a side of said first buoy that is opposite to said second buoy; and platelet poor plasma on a side of said second buoy that is opposite to said first buoy.
14. The device of claim 1, wherein said first and said second buoys are of a density that permits isolation of the following: multipotent cells between the first buoy and the second buoy; red blood cells on a side of said first buoy that is opposite to said second buoy, and bone marrow plasma on a side of said second buoy that is opposite to said first buoy.
15. The device of claim 1, further comprising a flexible conduit that connects said passage of the buoy guide post to said port.
16. The device of claim 1, further comprising a polymeric ring that extends around a cylindrical sidewall of said second buoy.
17. The device of claim 1, further comprising a first polymeric ring and a second polymeric ring that each extend around an outer diameter of said buoy guide post, said first polymeric ring and said second polymeric ring are positioned on opposite sides of said second valve.
18. A method for separating whole blood into different components comprising:
drawing the whole blood directly from a patient into a separation chamber through a port of the separation chamber, the separation chamber having a first buoy fixedly mounted to a buoy guide post and a second buoy slidably mounted to the buoy guide post, the buoy guide post having a first valve and a second valve, said first valve is closed and said second valve is open when said second buoy is in a first position, the whole blood is drawn into the separation chamber through the second valve into an area between the second buoy and a plunger slidably mounted in the separation chamber;
rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy to close the second valve and open the first valve and the components of the whole blood separate according to density such that red blood cells are between the port and the first buoy, platelet rich plasma is between the first buoy an the second buoy, and platelet poor plasma is between the second buoy and the plunger;
depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the platelet rich plasma through the first valve and out of the separation chamber through the port, to close the first valve, and to open the second valve;
applying the platelet rich plasma directly to an area of interest through an applicator attached to the port;
further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the platelet poor plasma through the second valve and out of the separation chamber through the port; and
applying the platelet poor plasma directly to an area of interest through an applicator attached to the port.
19. The method of claim 18, wherein the whole blood is drawn into the separation chamber through the port using a needle tip connected to the port with an extension nozzle.
20. The method of claim 18, wherein the platelet poor plasma is applied through an applicator attached directly to the port.
21. The method of claim 18, further comprising drawing the whole blood into a syringe that includes the separation chamber.
22. The method of claim 18, further comprising rotating the separation chamber such that both the first buoy and the second buoy move along a longitudinal axis of the separation chamber.
23. The method of claim 18, further comprising detaching a plunger handle from a plunger body of the plunger prior to rotating the separation chamber in the centrifuge and reattaching the plunger handle to the plunger body after the chamber is rotated in the centrifuge.
24. The method of claim 18, further comprising applying the platelet rich plasma and the platelet poor plasma directly to a wound site through a spray tip attached to the port.
25. The method of claim 18, further comprising restricting movement of the plunger prior to rotating the chamber.
26. A method for separating bone marrow aspirate into different components comprising:
drawing the bone marrow aspirate directly from a patient into a separation chamber through a port of the separation chamber, the separation chamber having a first buoy fixedly mounted to a buoy guide post and a second buoy slidably mounted to the guide post, the buoy guide post having a first valve and a second valve, said first valve is closed and said second valve is open when said second buoy is in a first position, the bone marrow aspirate is drawn into the separation chamber through the second valve into an area between the second buoy and a plunger slidably mounted in the separation chamber;
rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy to close the second valve and open the first valve and separate the components of the bone marrow aspirate according to density such that red blood cells are between the port and the first buoy, multipotent cells are between the first buoy an the second buoy, and bone marrow plasma is between the second buoy and the plunger;
depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the multipotent cells through the first valve and out of the separation chamber through the port, to close the first valve, and to open the second valve;
applying the multipotent cells directly to an area of interest through an applicator attached to the port;
further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the bone marrow plasma through the second valve and out of the separation chamber through the port; and
applying the bone marrow plasma directly to an area of interest through an applicator attached to the port.
27. A device having a separation chamber for separating components of a composition according to density comprising:
a port that provides fluid communication of the composition from an exterior of said chamber to an interior of said chamber;
a first buoy slidably mounted within said separation chamber; and
a second buoy slidably mounted within said separation chamber;
wherein said second buoy has a density such that after spinning said device for a suitable period of time a first component of said composition is isolated between said first buoy and said second buoy and a second component of said composition is isolated between said second buoy and an end of said separation chamber that is opposite to said port; and
wherein said port provides fluid communication of said first component and said second component from said interior of said chamber to said exterior of said chamber.
28. The device of claim 27, wherein said first buoy is connected to said second buoy.
29. The device of claim 28, wherein said first buoy and said second buoy are each slidably mounted to a buoy guide post extending along a longitudinal axis of said separation chamber.
30. The device of claim 27, wherein said first buoy is not connected to said second buoy.
31. A method for separating whole blood into different components comprising:
drawing the whole blood directly from a patient into a separation chamber through a port, the separation chamber having a first buoy slidably mounted in the separation chamber and a second buoy slidably mounted in the separation chamber, the whole blood is drawn into the separation chamber into an area between the second buoy and a plunger slidably mounted in the separation chamber;
rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy and the components of the whole blood separate according to density such that red blood cells are between the port and the first buoy, platelet rich plasma is between the first buoy an the second buoy, and platelet poor plasma is between the second buoy and the plunger;
depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the platelet rich plasma out of the separation chamber through the port;
applying the platelet rich plasma directly to an area of interest through an applicator attached to the port;
further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the platelet poor plasma out of the separation chamber through the port; and
applying the platelet poor plasma directly to an area of interest through the applicator attached to the port.
32. The method of claim 31, further comprising drawing the whole blood into the separation chamber through a needle tip attached to the port with an extension nozzle.
33. The method of claim 31, wherein the platelet poor plasma is applied to the area of interest with the applicator attached directly to the port.
Description
    FIELD
  • [0001]
    The present disclosure relates to sterile devices, systems, and methods for separating components of a composition, such as blood.
  • BACKGROUND
  • [0002]
    The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
  • [0003]
    Whole blood includes a variety of different fractions or parts. For example, human whole blood includes platelet rich plasma (PRP), platelet poor plasma (PPP), red blood cells (RBCs), and white blood cells (WBCs). These different blood fractions have a variety of clinical and experimental uses. A typical blood separation device must be loaded with a separate syringe that contains whole blood drawn from a source, such as a patient's blood vessel. The separation device is then centrifuged and a different syringe is used to draw the separated components from the device for delivery to a desired area. The use of separate syringes to load and unload the separation device is cumbersome, time consuming, and not cost efficient. Further, the possibility of contamination increases each time blood is transferred.
  • [0004]
    Thus, there is a need for an all-in-one separation device, and method of use, that can be used to draw blood directly from a source, such as a patient, can be centrifuged to separate different fractions of the whole blood according to density, and can be used to deposit select fractions at an area of interest.
  • SUMMARY
  • [0005]
    The present teachings provide for a device having a separation chamber for separating components of a composition according to density. The device includes a port, a buoy guide post, a first buoy, a second buoy, a passage, a first valve, and a second valve. The port provides fluid communication between an interior and an exterior of the separation chamber. The first buoy is fixedly mounted to the buoy guide post and slidably mounted within the separation chamber. The second buoy is slidably mounted to the buoy guide post and movable between a first position and a second position along the buoy guide post. The passage is defined in the buoy guide post and is in fluid communication with the port. The first valve in the buoy guide post is in fluid communication with the passage and an area of the separation chamber between the first buoy and the second buoy. The second valve in the buoy guide post is in fluid communication with the passage and an area of the separation chamber between the second buoy and an end of the separation chamber that is opposite to the port. The second buoy closes the first valve and opens the second valve when in the first position. The second buoy opens the first valve and closes the second valve when in the second position. The second buoy has a density such that after spinning the device for a suitable period of time a first component of the composition is isolated between the first buoy and the second buoy and a second component of the composition is isolated between the second buoy and the end of the separation chamber that is opposite to the port.
  • [0006]
    The present teachings further provide for a method for separating whole blood into different components. The method includes the following: drawing the whole blood directly from a patient into a separation chamber through a port of the separation chamber, the separation chamber having a first buoy fixedly mounted to a buoy guide post and a second buoy slidably mounted to the buoy guide post, the buoy guide post having a first valve and a second valve, the first valve is closed and the second valve is open when the second buoy is in a first position, the whole blood is drawn into the separation chamber through the second valve into an area between the second buoy and a plunger slidably mounted in the separation chamber; rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy to close the second valve and open the first valve and the components of the whole blood separate according to density such that red blood cells are between the port and the first buoy, platelet rich plasma is between the first buoy an the second buoy, and platelet poor plasma is between the second buoy and the plunger; depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the platelet rich plasma through the first valve and out of the separation chamber through the port, to close the first valve, and to open the second valve; applying the platelet rich plasma directly to an area of interest through an applicator attached to the port; further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the platelet poor plasma through the second valve and out of the separation chamber through the port; and applying the platelet poor plasma directly to an area of interest through an applicator attached to the port.
  • [0007]
    The present teachings also provide for a method for separating bone marrow aspirate into different components. The method includes: drawing the bone marrow aspirate directly from a patient into a separation chamber through a port of the separation chamber, the separation chamber having a first buoy fixedly mounted to a buoy guide post and a second buoy slidably mounted to the guide post, the buoy guide post having a first valve and a second valve, the first valve is closed and the second valve is open when the second buoy is in a first position, the bone marrow aspirate is drawn into the separation chamber through the second valve into an area between the second buoy and a plunger slidably mounted in the separation chamber; rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy to close the second valve and open the first valve and separate the components of the bone marrow aspirate according to density such that red blood cells are between the port and the first buoy, multipotent cells are between the first buoy an the second buoy, and bone marrow plasma is between the second buoy and the plunger; depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the multipotent cells through the first valve and out of the separation chamber through the port, to close the first valve, and to open the second valve; applying the multipotent cells directly to an area of interest through an applicator attached to the port; further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the bone marrow plasma through the second valve and out of the separation chamber through the port; and applying the bone marrow plasma directly to an area of interest through an applicator attached to the port.
  • [0008]
    The present teachings also provide for a device having a separation chamber for separating components of a composition according to density that includes a port, a first buoy, and a second buoy. The port provides fluid communication between an interior and an exterior of the separation chamber. The first buoy is slidably mounted within the separation chamber. The second buoy is slidably mounted within the separation chamber. The second buoy has a density such that after spinning the device for a suitable period of time a first component of the composition is isolated between the first buoy and the second buoy and a second component of the composition is isolated between the second buoy and an end of the separation chamber that is opposite to the port.
  • [0009]
    The present teachings further provide for a method for separating whole blood into different components. The method includes: drawing the whole blood directly from a patient into a separation chamber through a port, the separation chamber having a first buoy slidably mounted in the separation chamber and a second buoy slidably mounted in the separation chamber, the whole blood is drawn into the separation chamber into an area between the second buoy and a plunger slidably mounted in the separation chamber; rotating the chamber in a centrifuge for a sufficient period of time such that the second buoy moves to a second position in which the second buoy is spaced apart from the first buoy and the components of the whole blood separate according to density such that red blood cells are between the port and the first buoy, platelet rich plasma is between the first buoy an the second buoy, and platelet poor plasma is between the second buoy and the plunger; depressing the plunger to a first distance within the separation chamber to move the first buoy from the second position to the first position to force the platelet rich plasma out of the separation chamber through the port; applying the platelet rich plasma directly to an area of interest through an applicator attached to the port; further depressing the plunger to a second distance within the separation chamber that is greater than the first distance to force the platelet poor plasma out of the separation chamber through the port; and applying the platelet poor plasma directly to an area of interest through the applicator attached to the port.
  • [0010]
    Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
  • DRAWINGS
  • [0011]
    The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
  • [0012]
    FIG. 1A is a perspective view of a device for separating components of a multi-component composition according to the present teachings;
  • [0013]
    FIG. 1B is an exploded view of a plunger of the device of FIG. 1A;
  • [0014]
    FIG. 2A is a perspective cross-sectional view of the device of FIG. 1A taken along line 2A-2A of FIG. 1A;
  • [0015]
    FIG. 2B is a cross-sectional view of the device of FIG. 1A;
  • [0016]
    FIG. 3A is a cross-sectional view of a buoy guide post of the device of FIG. 1A;
  • [0017]
    FIG. 3B is an exploded perspective view of the buoy guide post of FIG. 3A;
  • [0018]
    FIG. 3C is an exploded perspective view of an additional buoy guide post that may be used with the device of FIG. 1A;
  • [0019]
    FIG. 4 is a cross-sectional view of the device of FIG. 1A, the device having been loaded with whole blood and spun for a suitable period of time to separate different components of whole blood according to density, platelet poor plasma being between a second buoy and a plunger base, platelet rich plasma being between the second buoy and a first buoy, and red blood cells being between the first buoy and an inlet/outlet port;
  • [0020]
    FIG. 4A is a top perspective view of the device as illustrated in FIG. 4 with the plunger base secured at a distal end of the device with a locking tab;
  • [0021]
    FIG. 5 is a cross-sectional view of the device of FIG. 1A showing the plunger being actuated to expel the platelet rich plasma from the device; and
  • [0022]
    FIG. 6 is a cross-sectional view of the device of FIG. 1A showing the plunger being actuated further to expel the platelet poor plasma from the device.
  • DETAILED DESCRIPTION
  • [0023]
    The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses.
  • [0024]
    With initial reference to FIGS. 1A, 1B, 2A, and 2B, a device for separating components of a multi-component composition according to the present teachings is illustrated at reference numeral 10. The device 10 is an all-in-one device that can be used to extract the multi-component composition directly from a source, such as a patient, can be centrifuged to separate different components of the composition according to density, and can be used to deposit select components of the composition directly at an area of interest, such as a wound site.
  • [0025]
    The device 10 generally includes a separation chamber 12, a port 14 for drawing the multi-component composition into the separation chamber 12 and for dispensing the separated components from the separation chamber 12, a plunger 16, and a buoy guide post 18 to which are mounted a first buoy 20 and a second buoy 22.
  • [0026]
    The separation chamber 12 can take the form of any suitable container having any suitable size or shape. For example and as illustrated throughout the figures, the separation chamber 12 can be cylindrical and can form the body of a syringe. The separation chamber 12 includes a longitudinal axis A.
  • [0027]
    The plunger 16 is slidably mounted within the separation chamber 12. In particular, the plunger 16 includes a plunger base 24 and a plunger handle 26. The plunger base 24 is seated within the separation chamber 12 and the plunger handle 26 extends from the plunger base 24 and from the separation chamber 12.
  • [0028]
    The plunger handle 26 can be removably attached to the base 24 in any suitable manner. For example and as illustrated in FIG. 1B, the plunger base 24 can include two opposing locking flanges 27 that extend from an upper surface of the base 24. The plunger handle 26 can include a locking tab 29 that mates with the flanges 27 upon placing the locking tab 29 between the flanges 27 and rotating the plunger handle 26 90 such that the locking tab 29 is under the flanges 27 and between the flanges 27 and the remainder of the base 24. The plunger 16 facilitates drawing of the multi-component composition into the separation chamber 12 by creating a vacuum therein and facilitates dispensing of the separated components therefrom, as further described herein. Syringe handles 23 extend from an exterior surface of the separation chamber 12 to facilitate operation and handling of the device 10.
  • [0029]
    The multi-component composition to be separated is drawn into, and dispensed from, the separation chamber 12 through the port 14. The port 14 can be any suitable through port that permits the passage of the multi-component composition to be separated, such as whole blood. For example, the port 14 can include a Luer lock 15. The port 14 can cooperate with a variety of devices, such as, for example, an extension nozzle 21 (FIG. 1).
  • [0030]
    The extension nozzle 21 can be any suitable connector, such as a Luer extension as illustrated. The nozzle 21 includes a first Luer lock connector 31 at a first end and a second Luer lock connector 33 at a second end. The first Luer lock 31 cooperates with the Luer lock 15 of the port 14. The second Luer lock 33 cooperates with a needle tip 25 (FIG. 1) or a spray tip (not shown). The second Luer lock 33 can be a Luer activated type valve that closes when the needle tip 25 is detached. As further described herein, the nozzle 21 facilitates use of the port 14 as both a draw port and expulsion port while maintaining sterility of the device 10.
  • [0031]
    The needle tip 25 is used to draw the composition into the separation chamber 12. Both the needle tip 25 and the spray tip facilitate application of various components of the composition to a delivery site, such as a wound site.
  • [0032]
    With additional reference to FIGS. 3A and 3B, the buoy guide post 18 includes a first end 28 and a second end 30 that is opposite to the first end 28. The buoy guide post 18 has a generally cylindrical shape. The guide post 18 defines a center passage or channel 32. The channel 32 extends from the first end 28 along a longitudinal axis B of the guide post 18. As illustrated, the channel 32 extends from the first end 28 and terminates just prior to reaching the second end 30.
  • [0033]
    With additional reference to FIG. 3C, an additional buoy guide post according to the present teachings is illustrated at reference number 18′. Features of the buoy guide post 18′ that are also included in the guide post 18 are designated with the same reference numbers, but include the prime (′) symbol. The description of the common features set forth herein with respect to the guide post 18 also applies to the guide post 18′. The primary difference between the guide post 18 and the guide post 18′ is that the channel 32′ extends to the second end 30′ to provide a conduit that extends completely through the buoy guide post 18′ from the first end 28′ to the second end 30′.
  • [0034]
    The guide post 18 further includes at least one first aperture 34 and at least one second aperture 36. The first aperture 34 is proximate to the first end 28 and the second aperture 36 is proximate to the second end 30. As illustrated, the guide post 18 includes two first apertures 34 and two second apertures 36. The two first apertures 34 and the two second apertures 36 are positioned at a 180 interval about an outer circumference of the guide post 18. Openings of each of the first apertures 34 and each of the second apertures 36 are located in annular recesses 37A and 37B respectively.
  • [0035]
    The first apertures 34 and the second apertures 36 each provide fluid communication between the channel 32 and the separation chamber 12. As illustrated in FIG. 3C, the guide post 18′ includes a third aperture 39 at the second end 30′. The third aperture 39 facilitates fluid communication between the channel 32′ and the separation chamber 12′.
  • [0036]
    On opposite sides of, and proximate to, the second aperture 36 are annular recesses 38A and 38B within the guide post 18. The annular recesses 38A and 38B each accommodate an o-ring 40A and 40B, respectively. As further described herein, the o-rings 40A and 40B facilitate movement of the second buoy 22 along the longitudinal axis B of the buoy guide post 18 between the first end 28 and the second end 30 and restrict passage of the composition past the o-rings 40A and 40B. The o-rings 40A and 40B can be made of any suitable material, such as a polymeric material. The buoy guide post 18 is positioned within the separation chamber 12 such that the longitudinal axis B of the guide post 18 extends along the longitudinal axis A of the separation chamber 12.
  • [0037]
    The first buoy 20 is generally shaped as a right cylinder. With additional reference to FIG. 4, the first buoy 20 includes a lower or first surface 42 and an upper or second surface 44 that is opposite to the lower surface 42. Extending between an outer circumference of the lower surface 42 and an outer circumference of the upper surface 44 is a circular sidewall 46. The upper surface 44 has a hemispherical shape and is concave with respect to the remainder of the first buoy 20. The lower surface 42 has a hemi-spherical shape and is convex with respect to the remainder of the first buoy 20.
  • [0038]
    A through bore 48 extends through an axial center of the first buoy 20. The buoy guide post 18 is positioned within the through bore 48 and is fixedly mounted thereto in any suitable manner, such as with a press-fit as illustrated or with a suitable adhesive. The buoy guide post 18 is mounted to the first buoy 20 such that the first end 28 of the guide post 18 is seated within the first buoy 20 proximate to the lower surface 42 with the first aperture 34 at the upper surface 44. In particular, the guide post 18 is positioned such that a majority of the first aperture 34 is recessed within the through bore 48 of the first buoy 20 with only a small portion of the first aperture 34 being slightly above the upper surface 44 at the center of the first buoy 20. Further, the first aperture 34 is spaced apart from the first buoy 20 as a result of being positioned within the recess 37A. Thus, there is a slight clearance between the first aperture 34 and the second buoy 22 through which the multi-component composition can pass to provide fluid communication between the first aperture and the area between the first buoy 20 and the second buoy 22. Because the upper surface 44 is concave, the first aperture 34 is recessed below, and does not pass across, a plane that extends completely across the upper surface 44 and is perpendicular to the sidewall 46.
  • [0039]
    The first buoy 20 is positioned within the separation chamber 12 such that the lower surface 42 faces the port 14 and the upper surface 44 faces the plunger 16. The circular sidewall 46 of the first buoy 20 faces an inner sidewall 50 of the separation chamber 12. When the device 10 is not being rotated or spun, the sidewall 46 contacts the inner sidewall 50 of the separation chamber 12 to restrict the passage of the multi-component composition being separated between the sidewall 46 and the inner sidewall 50.
  • [0040]
    The second buoy 22 is generally shaped as a right cone. The second buoy 22 includes a lower or first surface 52 and an upper or second surface 54 that is opposite to the lower surface 52. Extending between the lower surface 52 and the upper surface 54, around an outer periphery of the second buoy 22, is a cylindrical sidewall 56. The upper surface 54 slopes downward toward the sidewall 56. The lower surface 52 has a hemispherical shape and is convex with respect to the remainder of the second buoy 22. The sidewall 56 includes an annular recess 58 that extends around the sidewall 56. The annular recess 58 accommodates an o-ring 60 that extends around the cylindrical sidewall 56 of the second buoy 22. When the device 10 is not being rotated or spun, the sidewall 56 contacts the inner sidewall 50 of the separation chamber 12 to restrict the passage of the multi-component composition being separated between the sidewall 56 and the inner sidewall 50. The o-ring 60 can be made of any suitable material that facilitates movement of the second buoy 22 within the separation chamber 12 and restricts passage of the composition between the sidewall 56 and the inner sidewall 50. For example, the o-ring 60 can be made of a suitable polymeric material.
  • [0041]
    A through bore 62 extends through the center of the second buoy 22. The buoy guide post 18 is positioned within the through bore 62. The second buoy 22 is slidably mounted to the guide post 18 to allow the second buoy 22 to slidably move along the longitudinal axis A of the separation chamber 12 and the longitudinal axis B of the through bore 48. The second buoy 22 is seated on the o-rings 40A and 40B, which facilitate movement of the second buoy 22 and restricts the flow of the multi-component composition past the o-rings 40A and 40B. The second buoy 22 is slightly spaced apart from an outer surface 41 of the buoy guide post 18 due to the presence of the o-rings 40A and 40B.
  • [0042]
    The second buoy 22 can slidably move between a first position (FIGS. 2A and 2B) in which the second buoy 22 contacts the first buoy 20 and a second position (FIG. 4) in which the second buoy 22 is spaced apart from the first buoy 20. In the first position, the lower surface 52 of the second buoy 22 is flush with the upper surface 44 of the first buoy 20 to restrict passage of the multi-component composition through the first aperture 34 and into the separation chamber 12. When the second buoy 22 is in the first position, there is a passageway between the second aperture 36 and the separation chamber 12 to provide fluid communication between the channel 32 of the guide post 18 and the portion of the separation chamber 12 that is between the second buoy 22 and the plunger 16. The passageway is provided due to the clearance between the second buoy 22 and both the second aperture 36 and the o-ring 40B
  • [0043]
    In the second position, the second buoy 22 is spaced apart from the first buoy 20 and is proximate to the second end 30 of the guide post 18. The guide post 18 includes an annular tab 64 (FIG. 3A) at the second end 30 to prevent the second buoy 22 from sliding off of the guide post 18. With the second buoy 22 spaced apart from the first buoy 20, the clearance between the first aperture 34 and the first buoy 20 permits fluid communication between the channel 32 of the guide post 18 and the portion of the separation chamber 12 between the first buoy 20 and the second buoy 22. In the second position, the second buoy 22 mates with the o-ring 40B to obstruct the passageway between the second aperture 36 and the separation chamber 12 and to restrict fluid communication between the second aperture 36 and the area of the separation chamber 12 above the second buoy 22.
  • [0044]
    Thus, the first aperture 34 provides a first valve 65 and the second aperture 36 provides a second valve 67 between the separation chamber 12 and the channel 32 of the buoy guide post 18, which is in ultimate fluid communication with the port 14. Passage of the composition through the first and second apertures 34 and 36 is controlled by the position of the second buoy 22. When the second buoy 22 is in the first position, the second buoy 22 does not obstruct the flow of the composition through the second aperture 36, thus opening the second valve 67 between the channel 32 and the area of the separation chamber 12 above the second buoy 22. In the first position, the second buoy 22 restricts flow of the composition through the first aperture 34 and into the separation chamber 12, thus closing the first valve 65 between the channel 32 and the area of the separation chamber 12 between the first buoy 20 and the second buoy 22.
  • [0045]
    When the second buoy 22 is in the second position, the second buoy 22 obstructs the flow of the composition through the second aperture 36, thus closing the second valve 67 between the channel 32 and the area of the separation chamber 12 above the second buoy 22. In the second position, the second buoy 22 does not restrict passage of the composition through the first aperture 34, thus opening the first valve 65 between the channel 32 and the area of the separation chamber 12 between the first buoy 20 and the second buoy 22.
  • [0046]
    The first and the second buoys 20 and 22 can be made of any suitable material that will permit the buoys 20 and 22 to, upon rotating or spinning the device 10 in a centrifuge for a suitable period of time, move within the separation chamber 12 and settle between different components of the multi-component composition to be isolated. For example, when the device 10 is used for separating the components of whole blood, the buoys 20 and 22 can be made of a suitable high-density polyethylene material (HDPE). The HDPE of the buoys 20 and 22 will have a density that will permit separation of the whole blood such that red blood cells (RBCs) are between the port 14 and the first buoy 20; platelet rich plasma, buffy coat, or cell rich fractions (collectively “PRP”) are between the first buoy 20 and the second buoy 22 when the second buoy 22 is in the second position; and platelet poor plasma (PPP) is between the second buoy 22 and the plunger base 24.
  • [0047]
    The first buoy 20 is provided with a greater density than the second buoy 22. In particular, the first buoy 20 can have a density of between about 1.070 g/ml and about 1.095 g/ml, such as 1.075 g/ml. The second buoy 22 can have a density between about 0.93 g/ml and about 0.955 g/ml, such as 0.945 g/ml. The assembly including the first buoy 20, the second buoy 22, and the buoy guide post 18 can have an overall density of between about 1.02 g/ml and about 1.09 g/ml, such as 1.045 g/ml.
  • [0048]
    Mounted at the lower surface 42 of the first buoy 20 is a first connector 66. The first connector 66 is in fluid communication with the channel 32 and extends beyond the lower surface 42 of the first buoy 20. Mounted to the port 14 is a second connector 68. The second connector 68 extends from the port 14 to within the separation chamber 12. A flexible tube or conduit 70 is connected to the first connector 66 and the second connector 68 to provide fluid communication between the port 14 and the buoy guide post 18.
  • [0049]
    The device 10 can be used to separate most any liquid composition into its constituent components by density. With particular reference to FIGS. 2 and 4-6, operation of the device 10 to separate RBCs, PPP and PRP from whole blood is described below.
  • [0050]
    Whole blood is loaded into the separation chamber 12 of the device 10 with the first buoy 20 proximate to the port 14 and the second buoy 22 in the first position, as illustrated in FIGS. 2A and 2B. In the first position, the second buoy 22 is in contact with the first buoy 20 to obstruct passage of blood into the separation chamber 12 through the first aperture 34, thereby closing the first valve 65 defined by the first aperture 34, and to permit the passage of blood into the separation chamber 12 through the second aperture 36, thereby opening the second valve 67 defined by the second aperture 36. Prior to loading, the plunger 16 is positioned such that the plunger base 24 is seated deep within the separation chamber 12 and is distal to an end 72 (FIG. 1) of the separation chamber 12 that is opposite to the port 14.
  • [0051]
    With the first Luer lock 31 of the extension nozzle 21 coupled to the Luer lock 15 of the port 14 and the needle tip 25 coupled to the second Luer lock 33 of the extension nozzle 21, the needle tip 25 is inserted into a source of whole blood, such as a blood vessel of a patient. The plunger 16 is then pulled outward to move the plunger base 24 toward the end 72 of the chamber 12. As illustrated in FIG. 2B, withdrawing the plunger 16 creates a vacuum in the separation chamber 12 that draws the whole blood through the port 14, the tube 70, the channel 32 of the guide post 18, the second aperture 36, and into the separation chamber 12 between the second buoy 22 and the plunger base 24.
  • [0052]
    Any suitable amount of whole blood can be drawn, such as 30 ml or 60 ml for example. The size of the separation chamber will vary depending on the amount of whole blood to be separated. For example, if 30 ml of whole blood is to be separated, then the separation chamber 12 can be sized to hold about 51 ml of fluid. If 60 ml of whole blood is to be separated, then the separation chamber 12 can be sized to hold about 94 ml of fluid. The diameter of the first and the second buoys 20 and 22 can be modified to fit chambers 12 of different diameters. The density of the buoys 20 and 22 can remain the same regardless of the diameters of the first and the second buoys.
  • [0053]
    After the blood is loaded into the separation chamber 12, the plunger handle 26 can be removed from the plunger base 24 by rotating the plunger handle 26 90 so that the locking tab 29 no longer engages the flanges 27 and the needle tip 25 can be removed from the second Luer lock connector 33 of the nozzle 21. If the Luer lock connector 33 is a Luer valve it will close upon removal of the needle tip 25. The Luer lock connector 33 can also be closed with a suitable sterile cover 74 (FIG. 4).
  • [0054]
    To prevent the plunger base 24 from moving and applying pressure on the whole blood in the chamber 12 as the device 10 is spun, the plunger base 24 can be provided with a density that is less than blood. A suitable locking device can also be used to secure the plunger base 24. For example and as illustrated in FIGS. 4 and 4A, with the plunger base 24 positioned generally co-planar with the syringe handles 23, a locking tab 76 can be inserted beneath the locking flanges 27 so that it rests on the syringe handles 23 and restricts movement of the plunger base 24.
  • [0055]
    With the whole blood seated between the second buoy 22 and the plunger base 24, the device 10 is ready to be spun to separate the components of whole blood according to density. The device 10 is spun using a suitable rotational device, such as a centrifuge.
  • [0056]
    The device 10 can be spun for any suitable period of time to separate the different components of blood. For example, the device 10 can be spun for about 12 to about 15 minutes at about 3,200 rpm. As the device 10 spins, the inner sidewall 50 of the separation chamber 12 flexes or expands outward from the longitudinal axis A of the separation chamber 12 to provide a clearance between the sidewall 46 of the first buoy 20 and the inner sidewall 50, as well as between the sidewall 56 of the second buoy 22 and the inner sidewall 50 to allow the first and the second buoys 20 and 22 to move within the separation chamber 12 and allow the whole blood to move past the first and the second buoys 20 and 22.
  • [0057]
    As the device 10 is rotated, the different blood components separate according to density. Further, the first and second buoys 20 and 22 slidably move along the longitudinal axis A of the separation chamber 12 until the buoys reach a position where the density of each of the buoys 20 and 22 is proximate to, or matches, the density of surrounding blood components. In particular and as illustrated in FIG. 4, the first buoy 20 moves away from the port 14 to a position between the RBCs and the PRP. The second buoy 22 moves to the second position such that the second buoy 22 is spaced apart from the first buoy 20 with the PRP between the first buoy 20 and the second buoy 22. The PPP settles between the second buoy 22 and the plunger base 24. In the second position, the second buoy 22 opens the first valve 65 between the separation chamber 12 and the channel 32 defined by the first aperture 34 and closes the second valve 67 defined by the second aperture 36.
  • [0058]
    To withdraw the different blood components from the separation chamber 12, the device 10 is removed from the rotational device, the plunger handle 26 is reattached to the plunger base 24, the extension nozzle 21 is removed, and a suitable applicator, such as a spray tip or a new sterile needle tip 25A, is coupled directly to the Luer lock 15 of the port 14. Thus, the port 14 is both an intake port and an expulsion port.
  • [0059]
    To maintain sterility of the port 14, the device is packaged with the extension nozzle 21 attached to the port 14. The port 14 is shielded from the environment until after centrifugation when the extension nozzle 21 is removed. Thus, the port 14 is only exposed to the environment once, which enhances the sterility of the port 14.
  • [0060]
    As illustrated in FIG. 5, the plunger 16 is pushed into the separation chamber 12 to exert pressure on the PPP and the second buoy 22. The second buoy 22 is pushed back toward the first buoy 20 and to the first position. The presence of the o-ring 60 prevents passage of the PPP around the second buoy 22 as pressure is exerted on the PPP by the plunger 16. The o-ring 60 also facilitates movement of the second buoy 22 in response to activation of the plunger 16.
  • [0061]
    As the gap between the second buoy 22 and the first buoy 20 is closed, the PRP between the first buoy 20 and the second buoy 22 is forced through the first valve 65 defined by the first aperture 34. The PRP moves through the first aperture 34, the channel 32, and the flexible tube 70 to the port 14. From the port 14 the PRP is expelled from the device 10 through the needle tip 25A to a desired area.
  • [0062]
    The isolated PRP can be used for general wound healing and to facilitate the completion of most any orthopaedic procedure. More specifically, PRP can be used to treat bone fractures, non-unions, bony defects, tendinitis, and plantar fasciitis. PRP can also be used in conjunction with total joint replacement, gastric bypass, and bone grafting procedures.
  • [0063]
    With the second buoy 22 in the first position, the second valve 67 defined by the second aperture 36 in the guide post 18 is opened. As illustrated in FIG. 6, continued pressure exerted by the plunger 16 causes the PPP between the second buoy 22 and the plunger base 24 to pass through the second aperture 36. The PPP moves through the second aperture 36, the channel 32, and the flexible tube 70 to the port 14. From the port 14 the PPP is expelled from the device 10 through any suitable applicator attached to the port 14 and applied to a desired area.
  • [0064]
    PPP can be used for a variety of suitable purposes, such as to facilitate wound closure. PPP can also be used as a fibrin sealant, a fibrin glue, and for facial reconstruction.
  • [0065]
    RBCs are typically not extracted from the separation device 10. However, one skilled in the art will appreciate that the device 10 can be provided with a third valve between the port 14 and the first buoy 20 through which the RBCs may be withdrawn from the device 10.
  • [0066]
    Thus, the device 10 provides an all-in-one blood separation device. The device 10 can be introduced into a sterile field in a sterile package. After the device 10 is in the sterile field and removed from the sterile package, the device 10 can be used by sterile personnel as described above to draw blood directly from a source, such as a patient's blood vessel, separate the RBC, PPP, and PRP blood fractions during centrifugation, and deliver the fractions directly to a wound site to facilitate healing. The device 10 eliminates the need for separate syringes, or other devices, to draw the whole blood from the patient, transfer the drawn blood into a device suitable for centrifugation, and apply the separated blood fractions to a wound site. Therefore, the device 10 also eliminates any possibility of the blood being contaminated during transfer between different syringes or devices or from sterile to non-sterile fields.
  • [0067]
    The device 10 can also be used to separate components of bone marrow aspirate. For example, bone marrow aspirate can be obtained using any suitable bone marrow aspiration device, such as that described in U.S. patent application Ser. No. 12/210,372 titled Bone Marrow Aspiration Needle, filed on Sep. 15, 2008 and assigned to Biomet Biologics, LLC, which is hereby incorporated by reference. In particular, the device 10 can be attached directly to the inner aspiration needle described in U.S. patent application Ser. No. 12/210,372 through cooperation between the Luer lock 15 and the Luer lock of the inner aspiration needle.
  • [0068]
    To obtain bone marrow aspirate for separation, the bone marrow aspiration device, including the inner aspiration needle, is advanced into the bone cortex and ultimately into the bone marrow cavity from which the bone marrow aspirate is withdrawn. The bone marrow aspirate is drawn into the device 10 in the same manner that whole blood is, as described above. Any suitable amount of bone marrow aspirate can be used, such as about 300 cc, about 60 cc, or less than 60 cc. A suitable anticoagulant in a suitable amount is added to the bone marrow aspirate after it has been withdrawn from the bone marrow cavity.
  • [0069]
    The device 10 is centrifuged in the same manner as described above with respect to the separation of whole blood. Centrifugation causes the bone marrow aspirate to separate such that bone marrow plasma is isolated between the second buoy 22 and the plunger base 24. The heavy components of the bone marrow aspirate, such as the RBCs, are isolated between the first buoy 20 and the port 14. The multipotent cells are isolated between the first buoy 20 and the second buoy 22 in the gap formed between the first and the second buoys 20 and 22 when the second buoy 22 is in the second position. The multipotent cells and the bone marrow plasma can be removed from the device 10 in the same manner described above with respect to PRP and PPP.
  • [0070]
    When using the device 10 to isolate multipotent cells from bone marrow aspirate the first buoy 20 is provided with a greater density than the second buoy 22. The density of the first buoy 20 and the density of the second buoy 22 when the device 10 is used to separate components of bone marrow aspirate is generally the same as the density of the buoys 20 and 22 when the device 10 is used to separate whole blood.
  • [0071]
    The device 10 can be used to isolate most any liquid composition into its constituent components by density. In order to adapt the device 10 to separate different components, the density of the first buoy 20 and the second buoy 22 can be modified to approximate the density of the particular components to be isolated. As a result, the first and the second components to be isolated will be separated by the second buoy 22 with the first component isolated between the first buoy 20 and the second buoy 22 and the second component isolated between the second buoy 22 and the plunger base 24.
  • [0072]
    The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.
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Classifications
U.S. Classification604/506, 604/290, 210/96.1, 210/123
International ClassificationB01D17/12, B01D17/00, A61M5/31, A61M35/00
Cooperative ClassificationY10T436/2575, Y10T436/25375, Y10T436/25, B01L3/50215, G01N33/491, A61M1/029, A61M2202/0427, A61M2202/0429, A61M2202/0415, B01L2400/0409, A61M2202/0464, A61M2202/10, B01L3/0217, B01D17/12
European ClassificationG01N33/49C, A61M1/02K
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